KCT0008445已完成Unknown
A 12-week randomized, double-blind, placebo-controlled human study to evaluate the effectiveness and safety of Black Cumin Powder in reducing body of fat
ARI BnC0 个研究点目标入组 88 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •1)A person between the ages of 19 and 65 who is healthy and capable of normal physical activity
- •2) Those who are normal (18.5 ~ 24.9kg/m2) to overweight (25.0 ~ 29.9kg/m2) based on body mass index (BMI) and do not take medication
- •? If some (ethically permissible range) of persons with a BMI of 30.0 to 34.9 kg/m2 are included, those who take medication or need a prescription must
- •be excluded.
排除标准
- •1) Those who did not sign the subject consent form
- •2) Those who participated in other human application tests within 2 months before the screening test
- •3) A person whose body weight has changed by 5-10% within 3 months, and whose weight gain or loss is 5 kg or more
- •4) Those who have undergone obesity surgery within the last year
- •5) Those who have undergone surgery within the last 6 months
- •6) Those who are receiving or have received psychotropic drug treatment and psychological treatment due to mental illness (depression, schizophrenia, etc.)
- •7) A person diagnosed with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, or cerebrovascular disease, or a person with a history of using a pacemaker
- •8) Subjects undergoing drug treatment for diabetes or those with fasting blood sugar of 154 mg/dL or higher
- •9) Patients with gastroenteritis (Crohn's disease) / gastric resection / irritable bowel syndrome
- •10) Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or higher)
- •11) Those with a history of heart disease or cancer
- •12) Thyroid disease and those taking thyroid drug substitutes
- •13) Patients with malabsorption syndrome/autoimmune disease
- •14) Patients with liver failure and renal failure
- •15) Those who take dietary supplements or drugs that can affect blood sugar and lipid metabolism, body composition, and eicosanoid production (e.g. salicylates, product milk)
- •16) Patients with anemia/porphyria
- •17) Those suffering from pancreatic disease, those with a history of eating disorders
- •18) Pregnant or lactating women
- •19) Women within 6 months of giving birth
- •20) Those taking anti-obesity drugs
- •21) drug addict
- •22) Those who are taking blood sugar lowering drugs, insulin, or diabetes medications
- •23) Those taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity
- •24) Those who are taking drugs that affect carbohydrate and lipid metabolism, weight and hormones
- •25) Those taking immunosuppressants, proton pump inhibitors (PPI), H2 blockers, and non-steroidal anti-inflammatory drugs
- •26) Those taking blood cholesterol improving health functional food
- •27) Women who do not use the correct method of contraception
- •28) Those who have been on a diet for the past 3 years
- •29) Those who have participated in a weight loss program within the last 3 months
- •30) Those who consume excessive alcohol (more than 40g per day for men and more than 20g per day for women)
- •31) Excessive smokers (more than 25 cigarettes/day)
- •32) Those who consume excessive caffeine (daily intake of 400 mg or more)
- •33) There are side effects to vegetable oils
- •34) Those with serum creatinine of 1.5 mg/dL or higher
- •35) A person whose AST or ALT level is three times or more than the maximum normal level
- •36) Those who are judged unsuitable for the human body application test by the tester
- •37) Hepatitis B or C carriers
- •38) Those who are judged unfit to participate in the test by the test director for other reasons
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